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    Clinical Trial Results:
    A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination with Nivolumab (BMS-936558) in Subjects with Advanced Solid Tumors

    Summary
    EudraCT number
    		 2016-000603-91
    Trial protocol
    		 NL   DE   IT  
    Global end of trial date
    12 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Oct 2022
    First version publication date
    28 Oct 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CA013-004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02754141
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Jun 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the safety and tolerability of BMS-986179 administered alone and in combination with nivolumab.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Jun 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 40
    Country: Number of subjects enrolled
    France: 75
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Italy: 18
    Country: Number of subjects enrolled
    Australia: 8
    Country: Number of subjects enrolled
    Netherlands: 18
    Country: Number of subjects enrolled
    United States: 71
    Worldwide total number of subjects
    235
    EEA total number of subjects
    116
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    140
    From 65 to 84 years
    94
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 235 participants treated

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 P1A 150mg
    Arm description
    		 BMS-986179 150mg monotherapy leading into BMS-986179 150mg + Nivo 240 combo therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P1A 300mg
    Arm description
    		 BMS-986179 300mg monotherapy leading into BMS-986179 300mg + Nivo 240mg combo therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    nivolmulab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Arm title
    		 P1A 600mg
    Arm description
    		 BMS-986179 600mg monotherapy leading into BMS-986179 600mg + Nivo 240mg combo therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    nivolmulab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Arm title
    		 P1A 1200mg
    Arm description
    		 BMS-986179 1200mg monotherapy leading into BMS-986179 1200mg + Nivo 240mg combo therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolmulab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P1A 1600mg
    Arm description
    		 BMS-986179 1600mg monotherapy leading into BMS-986179 1600mg + Nivo 240mg combo therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolmulab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P1B Combo Therapy 150mg
    Arm description
    		 BMS-986179 150mg + Nivo 360mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
    Arm description
    		 BMS-986179 1200mg + Nivo 360mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
    Arm description
    		 BMS-986179 1200mg + Nivo 480mg
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P1B BMS986-179 1600mg
    Arm description
    		 BMS-986179 1600mg SC
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Arm title
    		 P2 Combo Pancreatic
    Arm description
    		 BMS-986179 1200mg Q2W + Nivo 240mg Q2W
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolmulab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P2 Combo Therapy NSCLC
    Arm description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolmulab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P2 Combo Melanoma
    Arm description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P2 Combo SCCHN
    Arm description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolmulab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P2 RCC Monotherapy
    Arm description
    		 BMS-986179 600mg Q2W monotherapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Arm title
    		 P2 RCC Combo Therapy
    Arm description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W combo therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolmulab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P2 Combo Prostate
    Arm description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P2 Combo Unassiged
    Arm description
    		 BMS-986179 1200mg Q2W + Nivo 240mg Q2W
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Investigational medicinal product name
    nivolmulab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    10mg/mL

    Arm title
    		 P2 Monotherapy Unassigned
    Arm description
    		 BMS-986179 600mg Q2W
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS986179
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    35mg/mL

    Number of subjects in period 1
    		P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 RCC Monotherapy P2 RCC Combo Therapy P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned
    Started
    14
    12
    12
    9
    12
    9
    8
    7
    18
    19
    31
    15
    15
    19
    18
    14
    2
    1
    Continuing to Combo Therapy
    12
    11
    12
    7
    10
    0
    0
    0
    0 [1]
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    0 [6]
    0 [7]
    0
    0 [8]
    0
    Crossing over to RCC combo therapy
    0 [9]
    0 [10]
    0 [11]
    0 [12]
    0 [13]
    0
    0
    0
    0 [14]
    0 [15]
    0 [16]
    0 [17]
    0 [18]
    3 [19]
    0 [20]
    0
    0 [21]
    0
    Completed
    1
    2
    4
    1
    2
    0
    0
    0
    6
    2
    11
    1
    1
    5
    5
    0
    2
    0
    Not completed
    13
    10
    8
    8
    10
    9
    8
    7
    12
    17
    20
    14
    14
    14
    13
    14
    0
    1
         Disease progression
    11
    7
    8
    5
    7
    7
    7
    6
    11
    16
    18
    13
    10
    12
    12
    14
    -
    1
         Study drug toxicity
    1
    1
    -
    -
    -
    -
    -
    -
    -
    -
    2
    1
    1
    -
    -
    -
    -
    -
         Request to discontinue
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    1
    1
    -
    -
    -
         Maximum clinical benefit
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         AE unrelated to study drug
    1
    1
    -
    1
    3
    2
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         No longer meets study criteria
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Other reasons
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    2
    -
    -
    -
    -
    -
         Withdrew consent
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
         Completed treatment as per protocol
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
         Not completing monotherapy
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [10] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [11] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [12] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [13] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [14] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [15] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [16] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [17] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [18] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [19] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [20] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm
    [21] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: No subjects in this milestone for this arm

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    P1A 150mg
    Reporting group description
    		 BMS-986179 150mg monotherapy leading into BMS-986179 150mg + Nivo 240 combo therapy

    Reporting group title
    P1A 300mg
    Reporting group description
    		 BMS-986179 300mg monotherapy leading into BMS-986179 300mg + Nivo 240mg combo therapy

    Reporting group title
    P1A 600mg
    Reporting group description
    		 BMS-986179 600mg monotherapy leading into BMS-986179 600mg + Nivo 240mg combo therapy

    Reporting group title
    P1A 1200mg
    Reporting group description
    		 BMS-986179 1200mg monotherapy leading into BMS-986179 1200mg + Nivo 240mg combo therapy

    Reporting group title
    P1A 1600mg
    Reporting group description
    		 BMS-986179 1600mg monotherapy leading into BMS-986179 1600mg + Nivo 240mg combo therapy

    Reporting group title
    P1B Combo Therapy 150mg
    Reporting group description
    		 BMS-986179 150mg + Nivo 360mg

    Reporting group title
    P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
    Reporting group description
    		 BMS-986179 1200mg + Nivo 360mg

    Reporting group title
    P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
    Reporting group description
    		 BMS-986179 1200mg + Nivo 480mg

    Reporting group title
    P1B BMS986-179 1600mg
    Reporting group description
    		 BMS-986179 1600mg SC

    Reporting group title
    P2 Combo Pancreatic
    Reporting group description
    		 BMS-986179 1200mg Q2W + Nivo 240mg Q2W

    Reporting group title
    P2 Combo Therapy NSCLC
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 Combo Melanoma
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 Combo SCCHN
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 RCC Monotherapy
    Reporting group description
    		 BMS-986179 600mg Q2W monotherapy

    Reporting group title
    P2 RCC Combo Therapy
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W combo therapy

    Reporting group title
    P2 Combo Prostate
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 Combo Unassiged
    Reporting group description
    		 BMS-986179 1200mg Q2W + Nivo 240mg Q2W

    Reporting group title
    P2 Monotherapy Unassigned
    Reporting group description
    		 BMS-986179 600mg Q2W

    Reporting group values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 RCC Monotherapy P2 RCC Combo Therapy P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned Total
    Number of subjects
    		 14 12 12 9 12 9 8 7 18 19 31 15 15 19 18 14 2 1 235
    Age Categorical
    Units: Participants
        <=18 years
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Between 18 and 65 years
    		 7 9 10 5 7 5 7 5 11 14 14 8 6 12 12 5 2 1 140
        >=65 years
    		 7 3 2 4 5 4 1 2 7 5 17 7 9 7 6 9 0 0 95
    Sex: Female, Male
    Units: Participants
        Female
    		 8 5 2 3 7 7 4 2 10 8 10 9 1 13 13 0 0 0 102
        Male
    		 6 7 10 6 5 2 4 5 8 11 21 6 14 6 5 14 2 1 133
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Asian
    		 0 1 1 0 0 0 0 1 3 0 0 0 1 0 0 1 0 0 8
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Black or African American
    		 0 0 0 1 0 1 1 0 0 0 1 0 0 1 0 0 0 5
        White
    		 14 11 10 8 12 8 7 5 14 19 30 15 14 18 18 13 1 1 218
        More than one race
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 1 0 0 0 0 1 1 0 0 0 0 0 0 0 1 0 4
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 2
        Not Hispanic or Latino
    		 5 4 6 4 5 4 3 7 11 11 1 3 2 12 12 0 2 0 92
        Unknown or Not Reported
    		 9 7 6 5 7 5 5 0 7 8 30 12 12 7 6 14 0 1 141
    Subject analysis sets

    Subject analysis set title
    P2 RCC Combo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 600mg Q2W + Nivo 480mg Q4W combo therapy

    Subject analysis set title
    P1A Combo Therapy 150mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 150mg + Nivo 240mg

    Subject analysis set title
    P1A Combo Therapy 300mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 300mg + Nivo 240mg

    Subject analysis set title
    P1A Combo Therapy 600mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 600mg + Nivo 240mg

    Subject analysis set title
    P1A Combo Therapy 1200mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 1200mg + Nivo 240mg

    Subject analysis set title
    P1A Combo Therapy 1600mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 1600mg + Nivo 240mg

    Subject analysis set title
    P2 Combo RCC Crossover
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Subject analysis sets values
    		 P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects
    18
    12
    11
    12
    7
    10
    3
    Age Categorical
    Units: Participants
        <=18 years
    0
        Between 18 and 65 years
    12
        >=65 years
    6
    Age continuous
    Units:
        
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Sex: Female, Male
    Units: Participants
        Female
    5
        Male
    13
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0
        Asian
    0
        Native Hawaiian or Other Pacific Islander
    0
        Black or African American
    0
        White
    18
        More than one race
    0
        Unknown or Not Reported
    0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    0
        Not Hispanic or Latino
    12
        Unknown or Not Reported
    6

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    P1A 150mg
    Reporting group description
    		 BMS-986179 150mg monotherapy leading into BMS-986179 150mg + Nivo 240 combo therapy

    Reporting group title
    P1A 300mg
    Reporting group description
    		 BMS-986179 300mg monotherapy leading into BMS-986179 300mg + Nivo 240mg combo therapy

    Reporting group title
    P1A 600mg
    Reporting group description
    		 BMS-986179 600mg monotherapy leading into BMS-986179 600mg + Nivo 240mg combo therapy

    Reporting group title
    P1A 1200mg
    Reporting group description
    		 BMS-986179 1200mg monotherapy leading into BMS-986179 1200mg + Nivo 240mg combo therapy

    Reporting group title
    P1A 1600mg
    Reporting group description
    		 BMS-986179 1600mg monotherapy leading into BMS-986179 1600mg + Nivo 240mg combo therapy

    Reporting group title
    P1B Combo Therapy 150mg
    Reporting group description
    		 BMS-986179 150mg + Nivo 360mg

    Reporting group title
    P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
    Reporting group description
    		 BMS-986179 1200mg + Nivo 360mg

    Reporting group title
    P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
    Reporting group description
    		 BMS-986179 1200mg + Nivo 480mg

    Reporting group title
    P1B BMS986-179 1600mg
    Reporting group description
    		 BMS-986179 1600mg SC

    Reporting group title
    P2 Combo Pancreatic
    Reporting group description
    		 BMS-986179 1200mg Q2W + Nivo 240mg Q2W

    Reporting group title
    P2 Combo Therapy NSCLC
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 Combo Melanoma
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 Combo SCCHN
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 RCC Monotherapy
    Reporting group description
    		 BMS-986179 600mg Q2W monotherapy

    Reporting group title
    P2 RCC Combo Therapy
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W combo therapy

    Reporting group title
    P2 Combo Prostate
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 Combo Unassiged
    Reporting group description
    		 BMS-986179 1200mg Q2W + Nivo 240mg Q2W

    Reporting group title
    P2 Monotherapy Unassigned
    Reporting group description
    		 BMS-986179 600mg Q2W

    Subject analysis set title
    P2 RCC Combo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 600mg Q2W + Nivo 480mg Q4W combo therapy

    Subject analysis set title
    P1A Combo Therapy 150mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 150mg + Nivo 240mg

    Subject analysis set title
    P1A Combo Therapy 300mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 300mg + Nivo 240mg

    Subject analysis set title
    P1A Combo Therapy 600mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 600mg + Nivo 240mg

    Subject analysis set title
    P1A Combo Therapy 1200mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 1200mg + Nivo 240mg

    Subject analysis set title
    P1A Combo Therapy 1600mg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 1600mg + Nivo 240mg

    Subject analysis set title
    P2 Combo RCC Crossover
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Primary: Number of participants with drug related AEs, SAEs, AEs leading to discontinuation and deaths.

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    End point title
    		 Number of participants with drug related AEs, SAEs, AEs leading to discontinuation and deaths. [1] [2]
    End point description
    Number of participants with drug related adverse events (AE), drug related serious adverse events (SAE), drug related AEs Leading to discontinuation and drug related deaths
    End point type
    Primary
    End point timeframe
    From first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No subjects analyzed for this arm
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    12
    9
    12
    9
    8
    7
    18
    19
    31
    15
    15
    14
    2
    1
    18
    12
    11
    12
    7
    10
    3
    Units: Participants
        Adverse Events
    7
    4
    3
    4
    5
    5
    1
    2
    4
    11
    21
    7
    12
    8
    1
    0
    15
    7
    7
    6
    5
    7
    3
        Serious Adverse Events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    1
    2
    0
    1
    0
    1
    0
        AEs Leading to Discontinuation
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    1
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
        Deaths
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with a best overall response (BOR) at week 24

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    End point title
    		 Number of participants with a best overall response (BOR) at week 24 [3]
    End point description
    Best overall response (BOR) is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. CR or PR determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met.
    End point type
    Secondary
    End point timeframe
    from initial treatment to week 24
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    12
    9
    12
    9
    8
    7
    18
    19
    31
    15
    15
    14
    2
    1
    18
    12
    11
    12
    7
    10
    3
    Units: Participants
        Complete Response
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Partial Response
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    1
    1
    2
    1
    1
    0
    No statistical analyses for this end point

    Secondary: Percentage of participants with an objective response rate (ORR) at week 24

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    End point title
    		 Percentage of participants with an objective response rate (ORR) at week 24 [4]
    End point description
    ORR is defined as the percentage of all treated participants whose BOR is either a CR or PR. Here "99999 and -99999" means not available
    End point type
    Secondary
    End point timeframe
    from initial treatment to week 24
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    12
    9
    12
    9
    8
    7
    18
    19
    31
    15
    15
    14
    2
    1
    18
    12
    11
    12
    7
    10
    3
    Units: Percentage of Participants
        number (confidence interval 95%)
    0 (0.0 to 84.2)
    0 (0.0 to 97.5)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (0.0 to 84.2)
    0 (0.0 to 33.6)
    0 (0.0 to 36.9)
    0 (0.0 to 41.0)
    0 (0.0 to 18.5)
    5.3 (0.1 to 26.0)
    3.2 (0.1 to 16.7)
    0 (0.0 to 21.8)
    13.3 (1.7 to 40.5)
    0 (0.0 to 23.2)
    0 (0.0 to 84.2)
    0 (0.0 to 97.5)
    0 (0.0 to 18.5)
    8.3 (0.2 to 38.5)
    9.1 (0.2 to 41.3)
    16.7 (2.1 to 48.4)
    14.3 (0.4 to 57.9)
    10.0 (0.3 to 44.5)
    0 (0.0 to 70.8)
    No statistical analyses for this end point

    Secondary: Progression free survival rate (PFSR) at week 24

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    End point title
    		 Progression free survival rate (PFSR) at week 24 [5]
    End point description
    PFSR at 24 weeks is defined as the percentage of treated participants remaining progression free and surviving at 24 weeks. Here "99999 and -99999" means not available
    End point type
    Secondary
    End point timeframe
    from initial treatment to week 24
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    12
    9
    12
    9
    8
    7
    18
    19
    31
    15
    15
    14
    2
    1
    18
    12
    11
    12
    7
    10
    3
    Units: Percentage
        number (confidence interval 95%)
    7.1 (1.3 to 98.7)
    8.3 (2.5 to 100.0)
    0 (-99999 to 99999)
    11.1 (1.3 to 98.7)
    16.7 (15.8 to 100.0)
    88.9 (51.8 to 99.7)
    87.5 (47.3 to 99.7)
    100.00 (59.0 to 100.0)
    88.9 (65.3 to 98.6)
    94.7 (74.0 to 99.9)
    71.0 (52.0 to 85.8)
    86.7 (59.5 to 98.3)
    80.0 (51.9 to 95.7)
    71.4 (41.9 to 91.6)
    50.0 (1.3 to 98.7)
    100.0 (2.5 to 100.0)
    72.2 (46.5 to 90.3)
    83.3 (51.6 to 97.9)
    72.7 (39.0 to 94.0)
    75.0 (42.8 to 94.5)
    57.1 (18.4 to 90.1)
    70.0 (34.8 to 93.3)
    66.7 (9.4 to 99.2)
    No statistical analyses for this end point

    Secondary: Median duration of response (DOR)

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    End point title
    		 Median duration of response (DOR) [6]
    End point description
    DOR (computed for all treated subjects with a BOR of CR or PR) is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first. Here "99999 and -99999" means not available
    End point type
    Secondary
    End point timeframe
    from first measure response approximately up to 25 months
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    12
    9
    12
    9
    8
    7
    18
    19
    31
    15
    15
    14
    2
    1
    18
    12
    11
    12
    7
    10
    3
    Units: Months
        median (full range (min-max))
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    3.90 (3.9 to 3.9)
    3.80 (3.8 to 3.8)
    99999 (-99999 to 99999)
    6.70 (3.8 to 9.6)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    17.40 (17.4 to 17.4)
    5.70 (5.7 to 5.7)
    9.30 (7.2 to 11.4)
    2.10 (2.1 to 2.1)
    24.40 (24.4 to 24.4)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Cmax

    		 Close Top of page
    End point title
    		 Cmax [7]
    End point description
    Cmax is defined as maximum plasma concentration of the drug Here "99999 and -99999" means not available
    End point type
    Secondary
    End point timeframe
    Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    0 [8]
    9
    12
    0 [9]
    0 [10]
    0 [11]
    18
    0 [12]
    0 [13]
    0 [14]
    0 [15]
    0 [16]
    0 [17]
    0 [18]
    0 [19]
    12
    11
    12
    7
    10
    0 [20]
    Units: ug/mL
    geometric mean (geometric coefficient of variation)
        Cycle 0 Day 1
    30.6524 ( 66 )
    94.9210 ( 99999 )
    ( )
    218.0423 ( 8 )
    499.5178 ( 10 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    28.8892 ( 25 )
    64.3400 ( 55 )
    141.3732 ( 26 )
    315.6963 ( 16 )
    453.5664 ( 27 )
    ( )
        Cycle 1 Day 1
    99999 ( 99999 )
    9999999999 ( 99999 )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    93.7415 ( 33 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        Cycle 1 Day 22
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    51.3637 ( 38 )
    99.3564 ( 47 )
    289.8829 ( 27 )
    722.2768 ( 32 )
    865.8497 ( 22 )
    ( )
        Cycle 2 Day 1
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    563.4487 ( 27 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        cycle 4 Day 15
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    Notes
    [8] - No subjects analyzed
    [9] - No subjects analyzed
    [10] - No subjects analyzed
    [11] - No subjects analyzed
    [12] - No subjects analyzed
    [13] - No subjects analyzed
    [14] - No subjects analyzed
    [15] - No subjects analyzed
    [16] - No subjects analyzed
    [17] - No subjects analyzed
    [18] - No subjects analyzed
    [19] - No subjects analyzed
    [20] - No subjects analyzed
    No statistical analyses for this end point

    Secondary: Tmax

    		 Close Top of page
    End point title
    		 Tmax [21]
    End point description
    Tmax is defined is the time to maximum plasma concentration Here "99999 and -99999" means not available
    End point type
    Secondary
    End point timeframe
    Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    0 [22]
    9
    12
    0 [23]
    0 [24]
    0 [25]
    18
    0 [26]
    0 [27]
    0 [28]
    0 [29]
    0 [30]
    0 [31]
    0 [32]
    0 [33]
    12
    11
    12
    7
    10
    0 [34]
    Units: hours
    median (full range (min-max))
        Cycle 0 Day 1
    2.409 (0.800 to 4.017)
    0.933 (0.933 to 0.933)
    ( to )
    2.992 (1.983 to 4.00)
    2.700 (2.400 to 3.00)
    ( to )
    ( to )
    ( to )
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    1.00 (0.967 to 8.250)
    2.942 (0.967 to 8.00)
    1.109 (0.867 to 24.050)
    4.000 (1.967 to 8.000)
    3.692 (1.783 to 24.117)
    ( to )
        Cycle 1 Day 1
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    96.200 (48.017 to 168.267)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
        Cycle 1 Day 22
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    4.000 (0.967 to 9.050)
    7.767 (4.067 to 95.950)
    4.000 (0.967 to 7.933)
    8.000 (2.100 to 10.050)
    4.000 (1.983 to 8.000)
    ( to )
        Cycle 2 Day 1
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    4.000 (1.967 to 24.667)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
        cycle 4 Day 15
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    Notes
    [22] - no subjects analyzed
    [23] - no subjects analyzed
    [24] - no subjects analyzed
    [25] - no subjects analyzed
    [26] - no subjects analyzed
    [27] - no subjects analyzed
    [28] - no subjects analyzed
    [29] - no subjects analyzed
    [30] - no subjects analyzed
    [31] - no subjects analyzed
    [32] - no subjects analyzed
    [33] - no subjects analyzed
    [34] - no subjects analyzed
    No statistical analyses for this end point

    Secondary: AUC (0-T)

    		 Close Top of page
    End point title
    		 AUC (0-T) [35]
    End point description
    Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration Here "99999 and -99999" means not available
    End point type
    Secondary
    End point timeframe
    Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
    Notes
    [35] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    0 [36]
    9
    12
    0 [37]
    0 [38]
    0 [39]
    18
    0 [40]
    0 [41]
    0 [42]
    0 [43]
    0 [44]
    0 [45]
    0 [46]
    0 [47]
    12
    11
    12
    7
    10
    0 [48]
    Units: h*ug/mL
    geometric mean (geometric coefficient of variation)
        Cycle 0 Day 1
    1414.4834 ( 76 )
    2565.0489 ( 99999 )
    ( )
    9362.9155 ( 39 )
    30716.0037 ( 47 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    1225.3679 ( 36 )
    3418.8393 ( 62 )
    9139.4853 ( 30 )
    23533.0706 ( 9 )
    31057.8588 ( 26 )
    ( )
        Cycle 1 Day 1
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    41672.2787 ( 35 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        Cycle 1 Day 22
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    3932.5889 ( 44 )
    9622.5237 ( 58 )
    27616.4807 ( 40 )
    74405.3428 ( 25 )
    92340.2959 ( 21 )
    ( )
        Cycle 2 Day 1
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    84384.9379 ( 36 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        cycle 4 Day 15
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    Notes
    [36] - no subjects analyzed
    [37] - no subjects analyzed
    [38] - no subjects analyzed
    [39] - no subjects analyzed
    [40] - no subjects analyzed
    [41] - no subjects analyzed
    [42] - no subjects analyzed
    [43] - no subjects analyzed
    [44] - no subjects analyzed
    [45] - no subjects analyzed
    [46] - no subjects analyzed
    [47] - no subjects analyzed
    [48] - no subjects analyzed
    No statistical analyses for this end point

    Secondary: AUC (Tau)

    		 Close Top of page
    End point title
    		 AUC (Tau) [49]
    End point description
    Area under the plasma concentration time-curve. AUC over the dosing interval. Here "99999 and -99999" means not available
    End point type
    Secondary
    End point timeframe
    Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
    Notes
    [49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    0 [50]
    0 [51]
    0 [52]
    12
    0 [53]
    0 [54]
    0 [55]
    18
    0 [56]
    0 [57]
    0 [58]
    0 [59]
    0 [60]
    0 [61]
    0 [62]
    0 [63]
    12
    11
    12
    7
    10
    0 [64]
    Units: h*ug/mL
    geometric mean (geometric coefficient of variation)
        Cycle 0 Day 1
    1417.4834 ( 76 )
    ( )
    ( )
    ( )
    34198.6293 ( 33 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    1307.7132 ( 33 )
    3546.1659 ( 59 )
    9139.4853 ( 30 )
    23533.0706 ( 9 )
    34970.3626 ( 12 )
    ( )
        Cycle 1 Day 1
    99999 ( 99999 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    40833.1977 ( 36 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        Cycle 1 Day 22
    99999 ( 99999 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    3975.0900 ( 46 )
    12326.2351 ( 44 )
    30044.3813 ( 35 )
    74405.3428 ( 25 )
    92340.2959 ( 21 )
    ( )
        Cycle 2 Day 1
    99999 ( 99999 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    92770.2634 ( 30 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        cycle 4 Day 15
    99999 ( 99999 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    Notes
    [50] - No subjects analyzed
    [51] - No subjects analyzed
    [52] - No subjects analyzed
    [53] - No subjects analyzed
    [54] - No subjects analyzed
    [55] - No subjects analyzed
    [56] - No subjects analyzed
    [57] - No subjects analyzed
    [58] - No subjects analyzed
    [59] - No subjects analyzed
    [60] - No subjects analyzed
    [61] - No subjects analyzed
    [62] - No subjects analyzed
    [63] - No subjects analyzed
    [64] - No subjects analyzed
    No statistical analyses for this end point

    Secondary: Ctau

    		 Close Top of page
    End point title
    		 Ctau [65]
    End point description
    Ctau is defined as the concentration of study drug at the end of the dosing interval. Here "99999 and -99999" means not available
    End point type
    Secondary
    End point timeframe
    Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 days
    Notes
    [65] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    0 [66]
    0 [67]
    0 [68]
    12
    0 [69]
    0 [70]
    0 [71]
    18
    0 [72]
    0 [73]
    0 [74]
    0 [75]
    0 [76]
    0 [77]
    0 [78]
    0 [79]
    12
    11
    12
    7
    10
    0 [80]
    Units: h*ug/mL
    geometric mean (geometric coefficient of variation)
        Cycle 0 Day 1
    1.9173 ( 99 )
    ( )
    ( )
    ( )
    82.2225 ( 82 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    0.8999 ( 74 )
    5.4691 ( 59 )
    25.9755 ( 32 )
    74.8859 ( 30 )
    99.0307 ( 14 )
    ( )
        Cycle 1 Day 1
    99999 ( 99999 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    30.0008 ( 51 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        Cycle 1 Day 22
    99999 ( 99999 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    14.5545 ( 54 )
    51.0567 ( 44 )
    126.4960 ( 37 )
    366.8165 ( 21 )
    466.5231 ( 32 )
    ( )
        Cycle 2 Day 1
    99999 ( 99999 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    52.9049 ( 71 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
        cycle 4 Day 15
    99999 ( 99999 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    Notes
    [66] - No Subjects Analyzed
    [67] - No Subjects Analyzed
    [68] - No Subjects Analyzed
    [69] - No Subjects Analyzed
    [70] - No Subjects Analyzed
    [71] - No Subjects Analyzed
    [72] - No Subjects Analyzed
    [73] - No Subjects Analyzed
    [74] - No Subjects Analyzed
    [75] - No Subjects Analyzed
    [76] - No Subjects Analyzed
    [77] - No Subjects Analyzed
    [78] - No Subjects Analyzed
    [79] - No Subjects Analyzed
    [80] - No Subjects Analyzed
    No statistical analyses for this end point

    Secondary: Mean change from baseline in CD73 assays

    		 Close Top of page
    End point title
    		 Mean change from baseline in CD73 assays [81]
    End point description
    Mean change from baseline in CD73 assays at the end of Part 1A treatment period Assays Measured: EHC CD73 H-score IHC CD73 Cytoplasm H-Score IHC CDS73 Membrane H-Score Here "99999 and -99999" means not available
    End point type
    Secondary
    End point timeframe
    approximately up to 95 weeks
    Notes
    [81] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P1A Combo Therapy 150mg P1A Combo Therapy 300mg P1A Combo Therapy 600mg P1A Combo Therapy 1200mg P1A Combo Therapy 1600mg P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    0 [82]
    9
    12
    0 [83]
    0 [84]
    0 [85]
    0 [86]
    0 [87]
    0 [88]
    0 [89]
    0 [90]
    0 [91]
    0 [92]
    0 [93]
    0 [94]
    12
    11
    0 [95]
    7
    10
    0 [96]
    Units: mean change from baseline
    arithmetic mean (standard error)
        EHC CD73 H-Score
    -33.790 ( 25.5200 )
    -103.700 ( 90.3400 )
    ( )
    -204.710 ( 99999 )
    -3.220 ( 51.7800 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    -33.790 ( 28.5200 )
    -103.700 ( 90.3400 )
    ( )
    -204.710 ( 99999 )
    -3.220 ( 51.7800 )
    ( )
        IHC CD73 Cytoplasm H-Score
    1.5 ( 2.60 )
    -0.3 ( 32.04 )
    ( )
    17.0 ( 99999 )
    0.0 ( 0.00 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    1.5 ( 2.60 )
    -0.3 ( 32.04 )
    ( )
    17.0 ( 99999 )
    0.0 ( 0.00 )
    ( )
        IHC CD73 Membrane H-Score
    7.3 ( 6.77 )
    8.7 ( 30.33 )
    ( )
    88.0 ( 99999 )
    0.00 ( 0.00 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    7.3 ( 6.77 )
    8.7 ( 30.33 )
    ( )
    88.0 ( 99999 )
    0.0 ( 0.00 )
    ( )
    Notes
    [82] - No subjects analyzed
    [83] - No subjects analyzed
    [84] - No subjects analyzed
    [85] - No subjects analyzed
    [86] - No subjects analyzed
    [87] - No subjects analyzed
    [88] - No subjects analyzed
    [89] - No subjects analyzed
    [90] - No subjects analyzed
    [91] - No subjects analyzed
    [92] - No subjects analyzed
    [93] - No subjects analyzed
    [94] - No subjects analyzed
    [95] - No subjects analyzed
    [96] - No subjects analyzed
    No statistical analyses for this end point

    Secondary: Number of participants with a positive anti-drug antibody (ADA) test.

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    End point title
    		 Number of participants with a positive anti-drug antibody (ADA) test. [97]
    End point description
    A participant with at least one ADA-positive sample relative to baseline at any time after initiation of treatment with BMS-986179 and nivolumab.
    End point type
    Secondary
    End point timeframe
    From first dose to last dose: Part 1: up to 95 weeks, Part 2 SC: up to 62 weeks, RCC Mono: up to 108 weeks, Part 2: up to 104 weeks
    Notes
    [97] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No subjects analyzed for this arm
    End point values
    		 P1A 150mg P1A 300mg P1A 600mg P1A 1200mg P1A 1600mg P1B Combo Therapy 150mg P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg P1B BMS986-179 1600mg P2 Combo Pancreatic P2 Combo Therapy NSCLC P2 Combo Melanoma P2 Combo SCCHN P2 Combo Prostate P2 Combo Unassiged P2 Monotherapy Unassigned P2 RCC Combo P2 Combo RCC Crossover
    Number of subjects analysed
    14
    12
    12
    9
    12
    9
    8
    7
    18
    19
    31
    15
    15
    14
    2
    1
    18
    3
    Units: Participants
        BMS-986179 ADA+
    5
    4
    8
    3
    2
    5
    6
    5
    11
    9
    22
    9
    6
    8
    1
    0
    14
    2
        Nivolumab ADA+
    0
    1
    0
    0
    0
    1
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
    Adverse event reporting additional description
    Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose:
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    P1A BMS1200
    Reporting group description
    		 BMS-986179 1200mg monotherapy

    Reporting group title
    P1A BMS150
    Reporting group description
    		 BMS-986179 150mg monotherapy

    Reporting group title
    P1A BMS300
    Reporting group description
    		 BMS-986179 300mg monotherapy

    Reporting group title
    P1A BMS600
    Reporting group description
    		 BMS-986179 600mg monotherapy

    Reporting group title
    P1A BMS600+NIV240
    Reporting group description
    		 BMS-986179 600mg + Nivo 240mg

    Reporting group title
    P1A BMS300+NIV240
    Reporting group description
    		 BMS-986179 3000mg + Nivo 240mg

    Reporting group title
    P1A BMS150+NIV240
    Reporting group description
    		 BMS-986179 150mg + Nivo 240mg

    Reporting group title
    P1A ALL MONO
    Reporting group description
    		 P1A all treated participants in monotherapy

    Reporting group title
    P1A BMS1200+NIV240
    Reporting group description
    		 BMS-986179 1200mg + Nivo 240mg

    Reporting group title
    P1A BMS1600
    Reporting group description
    		 BMS-986179 1600mg monotherapy

    Reporting group title
    P1B BMS1200+NIV360
    Reporting group description
    		 BMS-986179 1200mg + Nivo360mg

    Reporting group title
    P1B BMS150+NIV360
    Reporting group description
    		 BMS-986179 150mg + Nivo 360mg

    Reporting group title
    P1A ALL COMBO
    Reporting group description
    		 P1A all treated participants in combo therapy

    Reporting group title
    P1A BMS1600+NIV240
    Reporting group description
    		 BMS-986179 1600mg + Nivo 240mg

    Reporting group title
    P1B BMS1200+NIV480
    Reporting group description
    		 BMS-986179 1200mg + Nivo 480mg

    Reporting group title
    P1B BMS1600SC
    Reporting group description
    		 BMS-986179 1600mg SC

    Reporting group title
    P1B ALL COMBO
    Reporting group description
    		 All treated participants in P1B combo therapy period

    Reporting group title
    P2 PANCREATIC COMBO
    Reporting group description
    		 BMS-986179 1200mg Q2W + Nivo 240mg Q2W

    Reporting group title
    P2 NSCLC COMBO
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 MELANOMA COMBO
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 2 SCCHN COMBO
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 RCC COMBO
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 RCC MONO
    Reporting group description
    		 BMS-986179 600mg Q2W Monotherapy

    Reporting group title
    P2 RCC CROSSOVER
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 PROSTATE COMBO
    Reporting group description
    		 BMS-986179 600mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 NOT ASSIGNED MONO
    Reporting group description
    		 BMS-986179 600mg Q2W

    Reporting group title
    P2 NOT ASSIGNED COMBO
    Reporting group description
    		 BMS-986179 1200mg Q2W + Nivo 480mg Q4W

    Reporting group title
    P2 ALL COMBO
    Reporting group description
    		 All Treated participants in the P2 treatment period

    Reporting group title
    ALL COMBO (P1A+P1B+P2)
    Reporting group description
    		 All treated participants in P1A, P1B and P2 combo therapy periods

    Serious adverse events
    		 P1A BMS1200 P1A BMS150 P1A BMS300 P1A BMS600 P1A BMS600+NIV240 P1A BMS300+NIV240 P1A BMS150+NIV240 P1A ALL MONO P1A BMS1200+NIV240 P1A BMS1600 P1B BMS1200+NIV360 P1B BMS150+NIV360 P1A ALL COMBO P1A BMS1600+NIV240 P1B BMS1200+NIV480 P1B BMS1600SC P1B ALL COMBO P2 PANCREATIC COMBO P2 NSCLC COMBO P2 MELANOMA COMBO P2 2 SCCHN COMBO P2 RCC COMBO P2 RCC MONO P2 RCC CROSSOVER P2 PROSTATE COMBO P2 NOT ASSIGNED MONO P2 NOT ASSIGNED COMBO P2 ALL COMBO ALL COMBO (P1A+P1B+P2)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 9 (22.22%)
    3 / 14 (21.43%)
    4 / 12 (33.33%)
    1 / 12 (8.33%)
    9 / 12 (75.00%)
    6 / 11 (54.55%)
    5 / 12 (41.67%)
    13 / 59 (22.03%)
    3 / 7 (42.86%)
    3 / 12 (25.00%)
    7 / 8 (87.50%)
    7 / 9 (77.78%)
    28 / 52 (53.85%)
    5 / 10 (50.00%)
    4 / 7 (57.14%)
    11 / 18 (61.11%)
    18 / 24 (75.00%)
    8 / 19 (42.11%)
    14 / 31 (45.16%)
    8 / 15 (53.33%)
    11 / 15 (73.33%)
    11 / 18 (61.11%)
    5 / 19 (26.32%)
    1 / 3 (33.33%)
    4 / 14 (28.57%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    57 / 117 (48.72%)
    103 / 193 (53.37%)
         number of deaths (all causes)
    2
    2
    1
    0
    11
    11
    9
    7
    6
    2
    8
    9
    45
    8
    5
    18
    22
    14
    23
    14
    13
    9
    8
    1
    13
    0
    1
    88
    155
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    1 / 9 (11.11%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    2 / 24 (8.33%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    3 / 193 (1.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm progression
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    4 / 12 (33.33%)
    4 / 11 (36.36%)
    1 / 12 (8.33%)
    4 / 59 (6.78%)
    2 / 7 (28.57%)
    2 / 12 (16.67%)
    4 / 8 (50.00%)
    3 / 9 (33.33%)
    13 / 52 (25.00%)
    2 / 10 (20.00%)
    2 / 7 (28.57%)
    3 / 18 (16.67%)
    9 / 24 (37.50%)
    8 / 19 (42.11%)
    4 / 31 (12.90%)
    6 / 15 (40.00%)
    5 / 15 (33.33%)
    1 / 18 (5.56%)
    2 / 19 (10.53%)
    1 / 3 (33.33%)
    2 / 14 (14.29%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    27 / 117 (23.08%)
    49 / 193 (25.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 4
    0 / 4
    0 / 1
    0 / 4
    0 / 2
    0 / 2
    0 / 4
    0 / 3
    0 / 13
    0 / 2
    0 / 2
    0 / 3
    0 / 9
    0 / 8
    0 / 4
    0 / 6
    0 / 5
    0 / 1
    0 / 2
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 27
    0 / 49
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm progression
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tumour associated fever
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tumour pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    4 / 31 (12.90%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    4 / 117 (3.42%)
    4 / 193 (2.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    3 / 193 (1.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Performance status decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    4 / 193 (2.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    4 / 31 (12.90%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    6 / 117 (5.13%)
    8 / 193 (4.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngeal necrosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Adjustment disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device malfunction
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery dissection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    3 / 193 (1.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    2 / 15 (13.33%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemolysis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 18 (0.00%)
    2 / 24 (8.33%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    2 / 193 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    2 / 10 (20.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    3 / 193 (1.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intra-abdominal haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    2 / 193 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstruction gastric
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stenosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary obstruction
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune-mediated hepatitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    3 / 59 (5.08%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    6 / 193 (3.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    2 / 19 (10.53%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    3 / 193 (1.55%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infusion site infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis infective
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perinephric abscess
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    4 / 193 (2.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    1 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 3
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    3 / 193 (1.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular device infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 P1A BMS1200 P1A BMS150 P1A BMS300 P1A BMS600 P1A BMS600+NIV240 P1A BMS300+NIV240 P1A BMS150+NIV240 P1A ALL MONO P1A BMS1200+NIV240 P1A BMS1600 P1B BMS1200+NIV360 P1B BMS150+NIV360 P1A ALL COMBO P1A BMS1600+NIV240 P1B BMS1200+NIV480 P1B BMS1600SC P1B ALL COMBO P2 PANCREATIC COMBO P2 NSCLC COMBO P2 MELANOMA COMBO P2 2 SCCHN COMBO P2 RCC COMBO P2 RCC MONO P2 RCC CROSSOVER P2 PROSTATE COMBO P2 NOT ASSIGNED MONO P2 NOT ASSIGNED COMBO P2 ALL COMBO ALL COMBO (P1A+P1B+P2)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 9 (66.67%)
    11 / 14 (78.57%)
    8 / 12 (66.67%)
    8 / 12 (66.67%)
    12 / 12 (100.00%)
    11 / 11 (100.00%)
    11 / 12 (91.67%)
    45 / 59 (76.27%)
    7 / 7 (100.00%)
    12 / 12 (100.00%)
    6 / 8 (75.00%)
    9 / 9 (100.00%)
    50 / 52 (96.15%)
    9 / 10 (90.00%)
    6 / 7 (85.71%)
    17 / 18 (94.44%)
    21 / 24 (87.50%)
    17 / 19 (89.47%)
    31 / 31 (100.00%)
    14 / 15 (93.33%)
    14 / 15 (93.33%)
    17 / 18 (94.44%)
    19 / 19 (100.00%)
    3 / 3 (100.00%)
    13 / 14 (92.86%)
    1 / 1 (100.00%)
    1 / 2 (50.00%)
    110 / 117 (94.02%)
    181 / 193 (93.78%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Infected neoplasm
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    2
    Neoplasm malignant
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Tumour pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 11 (18.18%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    4 / 14 (28.57%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    6 / 117 (5.13%)
    9 / 193 (4.66%)
         occurrences all number
    0
    0
    1
    0
    0
    2
    0
    1
    0
    0
    0
    1
    2
    0
    0
    0
    1
    1
    0
    1
    0
    0
    1
    0
    4
    0
    0
    6
    9
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    Embolism
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Flushing
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Haematoma
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Hot flush
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    1 / 3 (33.33%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    3 / 193 (1.55%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    0
    3
    3
    Hypertension
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    3 / 18 (16.67%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    5 / 117 (4.27%)
    7 / 193 (3.63%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    1
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    1
    0
    0
    4
    1
    0
    1
    1
    0
    6
    8
    Hypotension
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    2 / 19 (10.53%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    3 / 15 (20.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    7 / 117 (5.98%)
    8 / 193 (4.15%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    2
    0
    2
    0
    1
    3
    1
    0
    0
    0
    0
    0
    7
    8
    Inferior vena cava stenosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Lymphoedema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Orthostatic hypotension
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    Thrombosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vasculitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Vena cava thrombosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Venous thrombosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    4 / 59 (6.78%)
    2 / 7 (28.57%)
    2 / 12 (16.67%)
    2 / 8 (25.00%)
    2 / 9 (22.22%)
    6 / 52 (11.54%)
    3 / 10 (30.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    4 / 24 (16.67%)
    5 / 19 (26.32%)
    14 / 31 (45.16%)
    5 / 15 (33.33%)
    1 / 15 (6.67%)
    2 / 18 (11.11%)
    9 / 19 (47.37%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    30 / 117 (25.64%)
    40 / 193 (20.73%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    1
    4
    3
    2
    2
    2
    7
    3
    0
    1
    4
    6
    19
    6
    1
    2
    10
    0
    2
    0
    2
    38
    49
    Axillary pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Catheter site pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Chest discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Chest pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Chills
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    2
    Device related thrombosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Early satiety
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    3 / 18 (16.67%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    0
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Face oedema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 18 (5.56%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    4 / 193 (2.07%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    2
    4
    Facial pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Fatigue
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    4 / 12 (33.33%)
    4 / 11 (36.36%)
    4 / 12 (33.33%)
    3 / 59 (5.08%)
    2 / 7 (28.57%)
    1 / 12 (8.33%)
    1 / 8 (12.50%)
    4 / 9 (44.44%)
    14 / 52 (26.92%)
    0 / 10 (0.00%)
    5 / 7 (71.43%)
    9 / 18 (50.00%)
    10 / 24 (41.67%)
    6 / 19 (31.58%)
    6 / 31 (19.35%)
    1 / 15 (6.67%)
    9 / 15 (60.00%)
    4 / 18 (22.22%)
    4 / 19 (21.05%)
    2 / 3 (66.67%)
    4 / 14 (28.57%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    32 / 117 (27.35%)
    56 / 193 (29.02%)
         occurrences all number
    1
    1
    0
    0
    4
    5
    4
    3
    2
    1
    1
    4
    15
    0
    5
    9
    10
    6
    6
    3
    9
    5
    7
    2
    4
    0
    0
    35
    60
    Feeling cold
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gait disturbance
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Generalised oedema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    Hyperthermia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    4 / 193 (2.07%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    2
    0
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    3
    5
    Inflammation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    3 / 31 (9.68%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    4 / 193 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    3
    4
    Influenza like illness
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    1 / 11 (9.09%)
    1 / 12 (8.33%)
    3 / 59 (5.08%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    4 / 52 (7.69%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    7 / 193 (3.63%)
         occurrences all number
    0
    0
    2
    1
    2
    2
    1
    3
    0
    0
    1
    0
    5
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    3
    9
    Infusion site joint swelling
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injection site reaction
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Localised oedema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    2
    3
    Malaise
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    1
    0
    2
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    Mucosal inflammation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    2 / 12 (16.67%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    3 / 52 (5.77%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    3 / 117 (2.56%)
    6 / 193 (3.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    3
    1
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    1
    3
    6
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 11 (9.09%)
    1 / 12 (8.33%)
    3 / 59 (5.08%)
    0 / 7 (0.00%)
    2 / 12 (16.67%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    3 / 52 (5.77%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    2 / 18 (11.11%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    3 / 31 (9.68%)
    0 / 15 (0.00%)
    3 / 15 (20.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    8 / 117 (6.84%)
    11 / 193 (5.70%)
         occurrences all number
    1
    0
    0
    0
    1
    1
    1
    3
    0
    2
    0
    0
    3
    0
    0
    2
    0
    1
    3
    0
    4
    0
    0
    0
    1
    0
    0
    9
    12
    Oedema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    Oedema peripheral
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    3 / 12 (25.00%)
    5 / 11 (45.45%)
    3 / 12 (25.00%)
    1 / 59 (1.69%)
    5 / 7 (71.43%)
    0 / 12 (0.00%)
    3 / 8 (37.50%)
    2 / 9 (22.22%)
    19 / 52 (36.54%)
    3 / 10 (30.00%)
    0 / 7 (0.00%)
    4 / 18 (22.22%)
    5 / 24 (20.83%)
    5 / 19 (26.32%)
    4 / 31 (12.90%)
    3 / 15 (20.00%)
    2 / 15 (13.33%)
    2 / 18 (11.11%)
    4 / 19 (21.05%)
    1 / 3 (33.33%)
    2 / 14 (14.29%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    19 / 117 (16.24%)
    43 / 193 (22.28%)
         occurrences all number
    0
    1
    0
    0
    3
    5
    3
    1
    5
    0
    4
    2
    19
    3
    0
    5
    6
    5
    4
    3
    2
    2
    4
    1
    2
    1
    0
    19
    44
    Pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    2 / 10 (20.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    2 / 19 (10.53%)
    2 / 31 (6.45%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    4 / 18 (22.22%)
    2 / 19 (10.53%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    10 / 117 (8.55%)
    12 / 193 (6.22%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    0
    1
    0
    2
    2
    2
    0
    4
    2
    1
    0
    0
    0
    11
    13
    Peripheral swelling
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 11 (9.09%)
    5 / 12 (41.67%)
    1 / 59 (1.69%)
    2 / 7 (28.57%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    10 / 52 (19.23%)
    1 / 10 (10.00%)
    2 / 7 (28.57%)
    6 / 18 (33.33%)
    2 / 24 (8.33%)
    4 / 19 (21.05%)
    2 / 31 (6.45%)
    3 / 15 (20.00%)
    0 / 15 (0.00%)
    2 / 18 (11.11%)
    3 / 19 (15.79%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    12 / 117 (10.26%)
    24 / 193 (12.44%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    6
    1
    3
    1
    0
    0
    12
    1
    2
    7
    2
    4
    3
    3
    0
    2
    3
    0
    1
    0
    0
    13
    27
    Xerosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    Immune system disorders
    Contrast media allergy
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Hypersensitivity
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Intermenstrual bleeding
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pelvic pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Testis discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    Vaginal discharge
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Cough
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    3 / 12 (25.00%)
    1 / 11 (9.09%)
    4 / 12 (33.33%)
    3 / 59 (5.08%)
    1 / 7 (14.29%)
    1 / 12 (8.33%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    14 / 52 (26.92%)
    5 / 10 (50.00%)
    2 / 7 (28.57%)
    3 / 18 (16.67%)
    3 / 24 (12.50%)
    4 / 19 (21.05%)
    9 / 31 (29.03%)
    3 / 15 (20.00%)
    1 / 15 (6.67%)
    2 / 18 (11.11%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    22 / 117 (18.80%)
    39 / 193 (20.21%)
         occurrences all number
    0
    1
    0
    1
    5
    1
    4
    3
    1
    1
    1
    0
    16
    5
    2
    3
    3
    4
    12
    3
    1
    3
    1
    0
    2
    0
    1
    26
    45
    Dysphonia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    2 / 12 (16.67%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    3 / 193 (1.55%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    3
    Dyspnoea
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    3 / 11 (27.27%)
    2 / 12 (16.67%)
    4 / 59 (6.78%)
    2 / 7 (28.57%)
    1 / 12 (8.33%)
    2 / 8 (25.00%)
    1 / 9 (11.11%)
    12 / 52 (23.08%)
    3 / 10 (30.00%)
    1 / 7 (14.29%)
    4 / 18 (22.22%)
    4 / 24 (16.67%)
    5 / 19 (26.32%)
    11 / 31 (35.48%)
    0 / 15 (0.00%)
    3 / 15 (20.00%)
    2 / 18 (11.11%)
    5 / 19 (26.32%)
    1 / 3 (33.33%)
    3 / 14 (21.43%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    26 / 117 (22.22%)
    42 / 193 (21.76%)
         occurrences all number
    1
    1
    0
    1
    2
    3
    2
    4
    2
    1
    2
    1
    12
    3
    1
    4
    4
    5
    13
    0
    3
    2
    7
    1
    3
    0
    1
    28
    44
    Dyspnoea exertional
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    0
    1
    0
    0
    0
    0
    2
    3
    Haemoptysis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    3
    3
    Hiccups
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Hypoxia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    Interstitial lung disease
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    Laryngeal haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 11 (9.09%)
    2 / 12 (16.67%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    5 / 52 (9.62%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    7 / 193 (3.63%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    2
    0
    0
    0
    0
    1
    5
    1
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    7
    Oropharyngeal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    3 / 193 (1.55%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    1
    0
    0
    1
    0
    1
    0
    0
    1
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    1
    3
    Pleural effusion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    1 / 19 (5.26%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    5 / 193 (2.59%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    1
    1
    1
    0
    0
    0
    3
    5
    Pleuritic pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pneumonitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    2
    3
    Pneumothorax
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    2 / 18 (11.11%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    4 / 117 (3.42%)
    4 / 193 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    2
    0
    0
    0
    0
    0
    4
    4
    Productive cough
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    3 / 31 (9.68%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    5 / 117 (4.27%)
    7 / 193 (3.63%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    1
    0
    0
    1
    1
    0
    3
    0
    1
    1
    0
    0
    0
    0
    0
    5
    7
    Pulmonary embolism
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Respiratory tract congestion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    Sinus congestion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Throat irritation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Upper respiratory tract inflammation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    Upper-airway cough syndrome
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    3
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    4 / 52 (7.69%)
    3 / 10 (30.00%)
    1 / 7 (14.29%)
    2 / 18 (11.11%)
    2 / 24 (8.33%)
    2 / 19 (10.53%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    6 / 117 (5.13%)
    12 / 193 (6.22%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    4
    3
    1
    2
    2
    2
    2
    0
    1
    1
    0
    0
    0
    0
    0
    6
    12
    Confusional state
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    2 / 59 (3.39%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    2
    0
    1
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    Depression
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    1
    3
    Hallucination
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Insomnia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    3 / 12 (25.00%)
    2 / 11 (18.18%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    7 / 52 (13.46%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    5 / 117 (4.27%)
    13 / 193 (6.74%)
         occurrences all number
    1
    0
    0
    0
    3
    2
    1
    1
    1
    0
    0
    0
    7
    0
    1
    1
    1
    0
    2
    1
    0
    1
    1
    0
    1
    0
    0
    5
    13
    Restlessness
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Sleep disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    2
    2
    Product issues
    Device dislocation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    2
    3
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    2 / 12 (16.67%)
    1 / 59 (1.69%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    4 / 52 (7.69%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    3 / 19 (15.79%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    8 / 193 (4.15%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    2
    1
    1
    0
    0
    1
    4
    0
    0
    1
    1
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    9
    Ammonia increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Amylase decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    Amylase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    4 / 52 (7.69%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    5 / 31 (16.13%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    7 / 117 (5.98%)
    11 / 193 (5.70%)
         occurrences all number
    0
    0
    0
    0
    2
    3
    0
    0
    0
    0
    0
    0
    6
    1
    0
    2
    0
    0
    7
    1
    0
    0
    1
    0
    1
    0
    0
    9
    15
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    3 / 59 (5.08%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    5 / 19 (26.32%)
    3 / 31 (9.68%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    9 / 117 (7.69%)
    12 / 193 (6.22%)
         occurrences all number
    2
    0
    1
    0
    1
    0
    1
    3
    0
    0
    0
    1
    2
    0
    0
    0
    1
    6
    3
    1
    0
    0
    0
    0
    0
    0
    0
    10
    13
    Blood alkaline phosphatase decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    4 / 31 (12.90%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    1 / 3 (33.33%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    8 / 117 (6.84%)
    10 / 193 (5.18%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    2
    0
    0
    1
    0
    1
    6
    0
    0
    1
    0
    2
    1
    0
    0
    11
    13
    Blood bilirubin increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    3 / 19 (15.79%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    4 / 117 (3.42%)
    5 / 193 (2.59%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    3
    2
    0
    0
    0
    0
    0
    0
    0
    0
    5
    7
    Blood cholesterol increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    Blood creatine phosphokinase MB increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Blood creatine phosphokinase decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    3 / 12 (25.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    3 / 52 (5.77%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    6 / 193 (3.11%)
         occurrences all number
    0
    0
    0
    0
    4
    0
    0
    0
    0
    0
    0
    0
    4
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    3
    7
    Blood creatinine increased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    1 / 11 (9.09%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    4 / 52 (7.69%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    5 / 31 (16.13%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 18 (5.56%)
    1 / 19 (5.26%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    8 / 117 (6.84%)
    13 / 193 (6.74%)
         occurrences all number
    1
    0
    0
    0
    3
    2
    1
    1
    0
    0
    0
    0
    6
    0
    1
    1
    1
    0
    5
    0
    1
    2
    3
    2
    0
    3
    0
    10
    17
    Blood glucose decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood iron decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    6 / 31 (19.35%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    8 / 117 (6.84%)
    9 / 193 (4.66%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    8
    1
    1
    0
    0
    0
    0
    0
    0
    10
    11
    Blood pressure increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Blood thyroid stimulating hormone decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    1
    0
    0
    0
    0
    0
    0
    0
    4
    4
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    4 / 193 (2.07%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    3
    5
    Blood triglycerides abnormal
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    Blood triglycerides increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    4 / 117 (3.42%)
    4 / 193 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    1
    0
    0
    4
    4
    Blood urea increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    4 / 117 (3.42%)
    4 / 193 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    2
    0
    0
    4
    4
    Blood uric acid increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    Blood urine present
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    C-reactive protein increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    0
    0
    0
    0
    0
    3
    3
    Electrocardiogram T wave inversion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    6 / 31 (19.35%)
    2 / 15 (13.33%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    10 / 117 (8.55%)
    12 / 193 (6.22%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    1
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    7
    2
    0
    1
    0
    2
    0
    0
    0
    12
    14
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    1
    1
    Glycosylated haemoglobin increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    2
    2
    Haemoglobin increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    1
    1
    Heart rate decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    7
    7
    Heart rate increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Immature granulocyte count increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    International normalised ratio increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    2
    Lipase decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    2
    2
    Lipase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    4 / 52 (7.69%)
    1 / 10 (10.00%)
    1 / 7 (14.29%)
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    1 / 19 (5.26%)
    8 / 31 (25.81%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    3 / 18 (16.67%)
    2 / 19 (10.53%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    14 / 117 (11.97%)
    19 / 193 (9.84%)
         occurrences all number
    0
    0
    0
    0
    5
    4
    0
    0
    0
    0
    0
    0
    10
    1
    1
    1
    1
    1
    12
    1
    1
    5
    2
    0
    0
    1
    0
    20
    31
    Liver function test increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    2 / 18 (11.11%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    4
    0
    0
    0
    1
    0
    5
    5
    Lymphocyte percentage decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    Monocyte count increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    Neutrophil count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neutrophil count increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    2 / 18 (11.11%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    1
    0
    3
    4
    Neutrophil percentage increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    Platelet count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Protein total decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    2
    2
    Red blood cell count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Red blood cell sedimentation rate decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    Red blood cells urine positive
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Transaminases increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    Tri-iodothyronine free decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    Troponin I increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Urine leukocyte esterase positive
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    Weight decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 11 (9.09%)
    2 / 12 (16.67%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    4 / 52 (7.69%)
    0 / 10 (0.00%)
    2 / 7 (28.57%)
    0 / 18 (0.00%)
    3 / 24 (12.50%)
    1 / 19 (5.26%)
    3 / 31 (9.68%)
    1 / 15 (6.67%)
    2 / 15 (13.33%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    2 / 3 (66.67%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    9 / 117 (7.69%)
    16 / 193 (8.29%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    2
    0
    0
    0
    0
    1
    4
    0
    2
    0
    3
    1
    3
    1
    2
    0
    0
    2
    0
    0
    0
    9
    16
    Weight increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    1 / 7 (14.29%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    1
    1
    1
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    White blood cell count increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    1
    0
    2
    3
    White blood cells urine positive
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    1
    0
    0
    0
    0
    0
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    Fall
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    1
    0
    0
    0
    3
    3
    Incision site pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Infusion related reaction
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    3 / 59 (5.08%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    2 / 19 (10.53%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    2 / 15 (13.33%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    6 / 117 (5.13%)
    8 / 193 (4.15%)
         occurrences all number
    0
    1
    1
    1
    0
    1
    0
    3
    0
    0
    0
    0
    2
    1
    0
    0
    0
    2
    0
    0
    2
    1
    0
    0
    1
    0
    0
    6
    8
    Post procedural pruritus
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Procedural nausea
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Procedural pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    2
    3
    Procedural site reaction
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rib fracture
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Skin abrasion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Stoma site pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Vascular access site pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Vascular access site rash
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Wound
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Wound dehiscence
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Cardiac failure
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    2
    Mitral valve disease
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    Palpitations
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    4 / 193 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    3
    4
    Sinoatrial block
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Sinus bradycardia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    2
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Aphasia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Burning sensation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Central nervous system mass
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Dizziness
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    2 / 18 (11.11%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    4 / 117 (3.42%)
    6 / 193 (3.11%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    1
    0
    1
    1
    0
    2
    0
    0
    1
    1
    0
    0
    0
    1
    2
    0
    0
    1
    0
    0
    4
    7
    Dizziness postural
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    2
    2
    Dysarthria
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Dysgeusia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    2
    3
    Headache
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    3 / 12 (25.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    9 / 59 (15.25%)
    2 / 7 (28.57%)
    3 / 12 (25.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    4 / 52 (7.69%)
    1 / 10 (10.00%)
    1 / 7 (14.29%)
    0 / 18 (0.00%)
    2 / 24 (8.33%)
    0 / 19 (0.00%)
    3 / 31 (9.68%)
    1 / 15 (6.67%)
    3 / 15 (20.00%)
    3 / 18 (16.67%)
    2 / 19 (10.53%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    10 / 117 (8.55%)
    16 / 193 (8.29%)
         occurrences all number
    2
    0
    1
    3
    0
    0
    1
    9
    2
    3
    0
    2
    4
    1
    1
    0
    3
    0
    3
    1
    4
    3
    4
    0
    0
    0
    0
    11
    18
    Hypoaesthesia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    2
    3
    Loss of consciousness
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Memory impairment
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Neuropathy peripheral
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    1 / 18 (5.56%)
    2 / 24 (8.33%)
    0 / 19 (0.00%)
    3 / 31 (9.68%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    4 / 117 (3.42%)
    8 / 193 (4.15%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    1
    0
    2
    0
    1
    1
    2
    0
    3
    0
    1
    0
    1
    0
    0
    0
    0
    4
    8
    Ophthalmic migraine
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    4 / 193 (2.07%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    1
    0
    0
    0
    1
    0
    3
    4
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    2
    Presyncope
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Restless legs syndrome
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Sciatica
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    Seizure
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Somnolence
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    4 / 193 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    3
    4
    Spinal cord compression
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Taste disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    Tremor
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 14 (7.14%)
    3 / 12 (25.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    3 / 11 (27.27%)
    3 / 12 (25.00%)
    9 / 59 (15.25%)
    0 / 7 (0.00%)
    3 / 12 (25.00%)
    3 / 8 (37.50%)
    1 / 9 (11.11%)
    8 / 52 (15.38%)
    2 / 10 (20.00%)
    1 / 7 (14.29%)
    2 / 18 (11.11%)
    5 / 24 (20.83%)
    2 / 19 (10.53%)
    9 / 31 (29.03%)
    3 / 15 (20.00%)
    3 / 15 (20.00%)
    4 / 18 (22.22%)
    2 / 19 (10.53%)
    2 / 3 (66.67%)
    2 / 14 (14.29%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    25 / 117 (21.37%)
    38 / 193 (19.69%)
         occurrences all number
    2
    1
    3
    0
    0
    6
    3
    9
    0
    3
    3
    1
    11
    2
    1
    2
    5
    2
    9
    4
    3
    4
    2
    2
    2
    2
    0
    26
    42
    Eosinophilia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    1
    0
    0
    0
    0
    0
    0
    0
    4
    4
    Hyperleukocytosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Leukocytosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    2
    2
    Lymphopenia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    2
    2
    Splenic vein thrombosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Thrombocytosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    4 / 31 (12.90%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    4 / 117 (3.42%)
    4 / 193 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    5
    0
    0
    0
    0
    0
    0
    0
    0
    5
    5
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Middle ear effusion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    Middle ear inflammation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Tinnitus
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Vertigo
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    0
    0
    0
    0
    0
    3
    3
    Vestibular disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    Eye disorders
    Amaurosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Conjunctival oedema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Diplopia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Dry eye
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    2 / 12 (16.67%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    3 / 52 (5.77%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    4 / 193 (2.07%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    2
    1
    0
    0
    0
    0
    3
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    4
    Eye disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    Eye irritation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    3
    Eye oedema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Eye pruritus
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    3 / 52 (5.77%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    1
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    Eyelid oedema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    Lacrimation increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    2 / 19 (10.53%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    2
    Ocular hyperaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Periorbital oedema
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 11 (9.09%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    3 / 52 (5.77%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    3 / 193 (1.55%)
         occurrences all number
    0
    1
    0
    0
    2
    1
    1
    1
    0
    0
    0
    0
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    Vision blurred
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    2 / 52 (3.85%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    2
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    Visual impairment
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Xerophthalmia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    2 / 18 (11.11%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Abdominal distension
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    2 / 12 (16.67%)
    2 / 59 (3.39%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    4 / 52 (7.69%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    2 / 18 (11.11%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    7 / 193 (3.63%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    2
    2
    0
    1
    0
    1
    4
    1
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    2
    7
    Abdominal pain
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    3 / 12 (25.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    5 / 59 (8.47%)
    1 / 7 (14.29%)
    1 / 12 (8.33%)
    2 / 8 (25.00%)
    1 / 9 (11.11%)
    5 / 52 (9.62%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    7 / 18 (38.89%)
    4 / 24 (16.67%)
    4 / 19 (21.05%)
    2 / 31 (6.45%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    11 / 117 (9.40%)
    20 / 193 (10.36%)
         occurrences all number
    2
    0
    2
    1
    3
    0
    1
    6
    4
    1
    2
    3
    8
    0
    2
    7
    7
    4
    2
    1
    1
    2
    0
    0
    2
    0
    0
    12
    27
    Abdominal pain lower
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    2 / 12 (16.67%)
    1 / 59 (1.69%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    4 / 52 (7.69%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    3 / 19 (15.79%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 18 (5.56%)
    4 / 19 (21.05%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    7 / 117 (5.98%)
    11 / 193 (5.70%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    2
    1
    1
    0
    0
    0
    4
    1
    0
    0
    0
    3
    3
    0
    1
    1
    4
    0
    0
    0
    0
    8
    12
    Abdominal tenderness
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Anal erythema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Anal haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    Anal pruritus
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Aphthous ulcer
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Ascites
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    2 / 18 (11.11%)
    1 / 24 (4.17%)
    7 / 19 (36.84%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    7 / 117 (5.98%)
    10 / 193 (5.18%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    2
    1
    7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    7
    10
    Cheilitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    2
    Colitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Constipation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    2 / 12 (16.67%)
    2 / 12 (16.67%)
    3 / 12 (25.00%)
    1 / 11 (9.09%)
    3 / 12 (25.00%)
    4 / 59 (6.78%)
    2 / 7 (28.57%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    3 / 9 (33.33%)
    11 / 52 (21.15%)
    2 / 10 (20.00%)
    3 / 7 (42.86%)
    4 / 18 (22.22%)
    7 / 24 (29.17%)
    4 / 19 (21.05%)
    5 / 31 (16.13%)
    1 / 15 (6.67%)
    2 / 15 (13.33%)
    3 / 18 (16.67%)
    3 / 19 (15.79%)
    0 / 3 (0.00%)
    4 / 14 (28.57%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    19 / 117 (16.24%)
    37 / 193 (19.17%)
         occurrences all number
    0
    0
    2
    2
    4
    1
    3
    4
    2
    0
    1
    3
    12
    2
    3
    4
    7
    4
    6
    1
    3
    3
    6
    0
    6
    1
    0
    23
    42
    Dental caries
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Diarrhoea
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    4 / 12 (33.33%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    1 / 11 (9.09%)
    6 / 12 (50.00%)
    6 / 59 (10.17%)
    3 / 7 (42.86%)
    1 / 12 (8.33%)
    1 / 8 (12.50%)
    2 / 9 (22.22%)
    14 / 52 (26.92%)
    2 / 10 (20.00%)
    1 / 7 (14.29%)
    2 / 18 (11.11%)
    4 / 24 (16.67%)
    1 / 19 (5.26%)
    9 / 31 (29.03%)
    4 / 15 (26.67%)
    3 / 15 (20.00%)
    7 / 18 (38.89%)
    6 / 19 (31.58%)
    2 / 3 (66.67%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    27 / 117 (23.08%)
    45 / 193 (23.32%)
         occurrences all number
    0
    1
    5
    0
    3
    1
    6
    7
    4
    1
    1
    4
    16
    2
    2
    2
    7
    2
    15
    4
    4
    9
    8
    3
    0
    0
    2
    39
    62
    Dry mouth
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    2 / 12 (16.67%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    3 / 9 (33.33%)
    6 / 52 (11.54%)
    2 / 10 (20.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    3 / 24 (12.50%)
    1 / 19 (5.26%)
    2 / 31 (6.45%)
    2 / 15 (13.33%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    6 / 117 (5.13%)
    15 / 193 (7.77%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    2
    0
    1
    0
    0
    3
    7
    3
    0
    0
    3
    1
    2
    2
    1
    0
    0
    0
    0
    0
    0
    6
    16
    Dyspepsia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    1 / 18 (5.56%)
    2 / 24 (8.33%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    4 / 193 (2.07%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    1
    1
    0
    1
    1
    2
    0
    0
    0
    2
    0
    1
    0
    0
    0
    0
    2
    5
    Dysphagia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    1
    0
    0
    3
    3
    Epigastric discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    2
    Faeces discoloured
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Flatulence
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    4 / 193 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    1
    2
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    4
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Gastrointestinal hypermotility
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    2 / 52 (3.85%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    1 / 19 (5.26%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    2 / 18 (11.11%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    4 / 117 (3.42%)
    7 / 193 (3.63%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    2
    1
    0
    0
    1
    1
    1
    0
    0
    2
    0
    0
    0
    0
    0
    4
    7
    Gingival pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    Glossitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    4 / 193 (2.07%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    4
    Lip blister
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Melaena
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    Mouth ulceration
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    2 / 12 (16.67%)
    3 / 12 (25.00%)
    0 / 12 (0.00%)
    7 / 11 (63.64%)
    4 / 12 (33.33%)
    6 / 59 (10.17%)
    1 / 7 (14.29%)
    1 / 12 (8.33%)
    1 / 8 (12.50%)
    3 / 9 (33.33%)
    13 / 52 (25.00%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    5 / 18 (27.78%)
    4 / 24 (16.67%)
    4 / 19 (21.05%)
    4 / 31 (12.90%)
    0 / 15 (0.00%)
    2 / 15 (13.33%)
    3 / 18 (16.67%)
    2 / 19 (10.53%)
    2 / 3 (66.67%)
    2 / 14 (14.29%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    17 / 117 (14.53%)
    34 / 193 (17.62%)
         occurrences all number
    0
    0
    2
    4
    0
    8
    4
    7
    1
    1
    2
    5
    15
    2
    0
    5
    7
    4
    4
    0
    2
    3
    3
    2
    3
    0
    0
    18
    40
    Odynophagia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    3
    Oral disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Oral lichen planus
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    2 / 19 (10.53%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    3
    Paraesthesia oral
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Proctalgia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Small intestinal haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    3
    Toothache
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    Vomiting
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    4 / 12 (33.33%)
    2 / 12 (16.67%)
    2 / 12 (16.67%)
    5 / 11 (45.45%)
    2 / 12 (16.67%)
    6 / 59 (10.17%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    2 / 9 (22.22%)
    12 / 52 (23.08%)
    3 / 10 (30.00%)
    1 / 7 (14.29%)
    4 / 18 (22.22%)
    3 / 24 (12.50%)
    3 / 19 (15.79%)
    4 / 31 (12.90%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    2 / 18 (11.11%)
    3 / 19 (15.79%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    11 / 117 (9.40%)
    26 / 193 (13.47%)
         occurrences all number
    0
    0
    6
    3
    2
    6
    2
    9
    0
    0
    0
    5
    14
    4
    1
    4
    6
    3
    4
    0
    1
    3
    3
    1
    0
    0
    0
    12
    32
    Hepatobiliary disorders
    Bile duct stenosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Cholestasis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    2
    3
    Hepatic cytolysis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    2 / 19 (10.53%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Immune-mediated hepatitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    Jaundice
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Portal vein thrombosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    Blister
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Decubitus ulcer
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Dermatitis acneiform
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    3 / 193 (1.55%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    2
    1
    1
    0
    0
    0
    3
    0
    0
    2
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    4
    Dermatitis contact
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Dry skin
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    2 / 12 (16.67%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    3 / 52 (5.77%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    2 / 15 (13.33%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    6 / 117 (5.13%)
    10 / 193 (5.18%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    1
    3
    0
    0
    0
    1
    0
    2
    2
    0
    1
    0
    1
    0
    0
    0
    6
    10
    Ecchymosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Erythema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    1 / 10 (10.00%)
    1 / 7 (14.29%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    2
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    Hyperhidrosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    2 / 59 (3.39%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    2
    2
    Lichenoid keratosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Night sweats
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    2
    3
    Onychoclasis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Pain of skin
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    2
    2
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    1 / 2 (50.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    1
    Photosensitivity reaction
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 14 (14.29%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    2 / 11 (18.18%)
    0 / 12 (0.00%)
    2 / 59 (3.39%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    3 / 9 (33.33%)
    5 / 52 (9.62%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    3 / 24 (12.50%)
    3 / 19 (15.79%)
    3 / 31 (9.68%)
    3 / 15 (20.00%)
    2 / 15 (13.33%)
    2 / 18 (11.11%)
    2 / 19 (10.53%)
    1 / 3 (33.33%)
    3 / 14 (21.43%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    17 / 117 (14.53%)
    25 / 193 (12.95%)
         occurrences all number
    0
    2
    0
    0
    1
    2
    0
    2
    1
    0
    0
    3
    5
    1
    0
    0
    3
    3
    3
    3
    2
    2
    2
    1
    3
    0
    0
    17
    25
    Rash
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    2 / 7 (28.57%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    5 / 52 (9.62%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    2 / 19 (10.53%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    2 / 18 (11.11%)
    2 / 19 (10.53%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    8 / 117 (6.84%)
    13 / 193 (6.74%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    1
    1
    3
    0
    0
    0
    7
    2
    0
    0
    0
    2
    1
    1
    1
    2
    2
    0
    1
    0
    0
    8
    15
    Rash macular
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    2 / 15 (13.33%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    4 / 117 (3.42%)
    7 / 193 (3.63%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    1
    2
    0
    0
    0
    1
    0
    0
    1
    2
    1
    0
    0
    0
    0
    0
    4
    7
    Rash pruritic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    1 / 7 (14.29%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Skin fissures
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Skin fragility
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Skin hyperpigmentation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Skin hypopigmentation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Skin induration
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Skin lesion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Skin ulcer
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    1 / 3 (33.33%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    2
    2
    Urticaria
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    3 / 193 (1.55%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    3
    Vitiligo
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Xeroderma
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Renal and urinary disorders
    Bladder spasm
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Chromaturia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    1
    1
    Chronic kidney disease
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    0
    0
    0
    2
    2
    Dysuria
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    1
    0
    0
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    Haematuria
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    2 / 18 (11.11%)
    0 / 19 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    5 / 117 (4.27%)
    5 / 193 (2.59%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    2
    0
    3
    0
    1
    0
    8
    8
    Hydronephrosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    Leukocyturia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Nocturia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Pollakiuria
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Proteinuria
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    3
    4
    Strangury
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Urinary incontinence
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    Urinary retention
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Hyperthyroidism
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    4 / 193 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    3
    4
    Hypothyroidism
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 11 (18.18%)
    2 / 12 (16.67%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    1 / 9 (11.11%)
    5 / 52 (9.62%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    2 / 24 (8.33%)
    1 / 19 (5.26%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    2 / 18 (11.11%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    4 / 117 (3.42%)
    11 / 193 (5.70%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    2
    0
    0
    0
    1
    1
    5
    1
    0
    0
    2
    1
    1
    0
    0
    3
    0
    0
    0
    0
    0
    5
    12
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Secondary adrenocortical insufficiency
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    2 / 11 (18.18%)
    3 / 12 (25.00%)
    3 / 59 (5.08%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    7 / 52 (13.46%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    5 / 18 (27.78%)
    1 / 24 (4.17%)
    1 / 19 (5.26%)
    4 / 31 (12.90%)
    2 / 15 (13.33%)
    2 / 15 (13.33%)
    2 / 18 (11.11%)
    4 / 19 (21.05%)
    0 / 3 (0.00%)
    3 / 14 (21.43%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    14 / 117 (11.97%)
    22 / 193 (11.40%)
         occurrences all number
    2
    1
    0
    0
    1
    3
    3
    3
    0
    0
    0
    1
    9
    2
    0
    5
    1
    1
    4
    3
    2
    2
    6
    0
    4
    1
    0
    16
    26
    Arthritis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    2 / 12 (16.67%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    3 / 52 (5.77%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    Back pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    2 / 8 (25.00%)
    3 / 9 (33.33%)
    8 / 52 (15.38%)
    4 / 10 (40.00%)
    2 / 7 (28.57%)
    2 / 18 (11.11%)
    7 / 24 (29.17%)
    1 / 19 (5.26%)
    3 / 31 (9.68%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    2 / 18 (11.11%)
    3 / 19 (15.79%)
    2 / 3 (66.67%)
    2 / 14 (14.29%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    12 / 117 (10.26%)
    27 / 193 (13.99%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    1
    1
    1
    0
    2
    4
    8
    4
    2
    2
    8
    1
    4
    1
    1
    2
    3
    2
    2
    1
    0
    13
    29
    Bone pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    2 / 19 (10.53%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    4 / 193 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    1
    1
    0
    0
    4
    0
    0
    0
    0
    2
    4
    Clubbing
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    Coccydynia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Flank pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    2 / 18 (11.11%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    4 / 193 (2.07%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    1
    0
    1
    0
    3
    0
    0
    2
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    1
    5
    Joint range of motion decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    2
    Joint stiffness
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Joint swelling
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    2
    2
    Limb discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Mobility decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    Muscle spasms
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 11 (0.00%)
    2 / 12 (16.67%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    5 / 52 (9.62%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    3 / 19 (15.79%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    4 / 117 (3.42%)
    9 / 193 (4.66%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    2
    0
    0
    0
    0
    0
    5
    1
    0
    0
    0
    0
    3
    0
    0
    0
    3
    0
    2
    0
    0
    5
    10
    Muscular weakness
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    1 / 10 (10.00%)
    1 / 7 (14.29%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    4 / 117 (3.42%)
    7 / 193 (3.63%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    2
    1
    1
    0
    1
    0
    0
    1
    1
    0
    1
    0
    2
    0
    0
    4
    7
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    3 / 12 (25.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    3 / 52 (5.77%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    1 / 19 (5.26%)
    3 / 31 (9.68%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    4 / 117 (3.42%)
    8 / 193 (4.15%)
         occurrences all number
    0
    0
    0
    1
    3
    0
    0
    1
    0
    0
    1
    0
    3
    0
    0
    1
    1
    1
    3
    0
    0
    0
    0
    0
    0
    0
    0
    4
    8
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    3 / 31 (9.68%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    4 / 117 (3.42%)
    5 / 193 (2.59%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    3
    1
    0
    0
    0
    0
    0
    0
    0
    4
    5
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Myalgia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    2 / 11 (18.18%)
    0 / 12 (0.00%)
    2 / 59 (3.39%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    3 / 52 (5.77%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    2 / 19 (10.53%)
    2 / 31 (6.45%)
    4 / 15 (26.67%)
    2 / 15 (13.33%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    2 / 14 (14.29%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    13 / 117 (11.11%)
    17 / 193 (8.81%)
         occurrences all number
    0
    0
    0
    1
    0
    2
    0
    2
    0
    1
    0
    1
    3
    1
    0
    0
    1
    2
    2
    4
    2
    1
    0
    0
    2
    0
    0
    13
    17
    Myopathy
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Neck pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    5 / 193 (2.59%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    0
    3
    0
    0
    0
    0
    0
    2
    0
    0
    1
    0
    0
    0
    0
    0
    3
    6
    Osteoarthritis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 14 (14.29%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 11 (9.09%)
    1 / 12 (8.33%)
    2 / 59 (3.39%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    4 / 52 (7.69%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    2 / 18 (11.11%)
    0 / 24 (0.00%)
    3 / 19 (15.79%)
    3 / 31 (9.68%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    3 / 18 (16.67%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    11 / 117 (9.40%)
    15 / 193 (7.77%)
         occurrences all number
    0
    2
    0
    0
    1
    1
    1
    2
    1
    0
    0
    0
    4
    0
    0
    2
    0
    3
    3
    1
    1
    3
    0
    0
    0
    2
    0
    11
    15
    Sarcopenia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Trismus
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    2
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Bronchitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    2 / 10 (20.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    4 / 193 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    2
    4
    Conjunctivitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    Cystitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    3
    3
    Ear infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Escherichia infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Fungal infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    Furuncle
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Herpes virus infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Herpes zoster
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    Influenza
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    2
    2
    Laryngitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    Localised infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Mucosal infection
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nail infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    Nasal herpes
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    3 / 52 (5.77%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    4 / 193 (2.07%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    3
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    4
    Onychomycosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    1
    1
    Oral herpes
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Oral infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    Otitis externa
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Periodontitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    Pharyngitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    3 / 52 (5.77%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    4 / 15 (26.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    5 / 117 (4.27%)
    8 / 193 (4.15%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    3
    1
    0
    0
    0
    0
    1
    0
    5
    0
    0
    0
    0
    0
    0
    6
    9
    Pneumonia aspiration
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Propionibacterium infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    Purulent discharge
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Renal abscess
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    Rhinitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    2 / 31 (6.45%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    2 / 19 (10.53%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    4 / 193 (2.07%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    2
    0
    0
    0
    2
    0
    0
    0
    0
    2
    4
    Sepsis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    0 / 193 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Skin infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    2
    Tooth abscess
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    2
    Tooth infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    3 / 52 (5.77%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    0 / 18 (0.00%)
    2 / 24 (8.33%)
    1 / 19 (5.26%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    8 / 193 (4.15%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    1
    0
    0
    1
    3
    0
    1
    0
    2
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    3
    8
    Urinary tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    2 / 12 (16.67%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    4 / 52 (7.69%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    4 / 18 (22.22%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    7 / 117 (5.98%)
    12 / 193 (6.22%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    1
    0
    4
    1
    0
    1
    1
    0
    1
    0
    1
    4
    2
    0
    1
    0
    0
    7
    12
    Vaginal infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    1 / 9 (11.11%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Viral infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    2 / 193 (1.04%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    Wound infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    1 / 117 (0.85%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    2 / 12 (16.67%)
    1 / 12 (8.33%)
    2 / 12 (16.67%)
    1 / 11 (9.09%)
    6 / 12 (50.00%)
    3 / 59 (5.08%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    3 / 9 (33.33%)
    11 / 52 (21.15%)
    2 / 10 (20.00%)
    0 / 7 (0.00%)
    6 / 18 (33.33%)
    3 / 24 (12.50%)
    6 / 19 (31.58%)
    5 / 31 (16.13%)
    1 / 15 (6.67%)
    3 / 15 (20.00%)
    3 / 18 (16.67%)
    5 / 19 (26.32%)
    2 / 3 (66.67%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    21 / 117 (17.95%)
    35 / 193 (18.13%)
         occurrences all number
    0
    0
    2
    1
    2
    1
    6
    3
    0
    0
    0
    4
    11
    2
    0
    6
    4
    6
    6
    1
    3
    3
    7
    2
    1
    0
    0
    22
    37
    Dehydration
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    2 / 7 (28.57%)
    2 / 18 (11.11%)
    2 / 24 (8.33%)
    2 / 19 (10.53%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    4 / 117 (3.42%)
    8 / 193 (4.15%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    1
    1
    0
    0
    0
    0
    2
    0
    2
    2
    2
    2
    1
    0
    0
    1
    0
    0
    0
    0
    0
    4
    8
    Folate deficiency
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    2 / 18 (11.11%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    0
    0
    0
    0
    3
    3
    Glucose tolerance impaired
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    0 / 31 (0.00%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    0 / 117 (0.00%)
    1 / 193 (0.52%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Hypercalcaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    1 / 9 (11.11%)
    2 / 52 (3.85%)
    1 / 10 (10.00%)
    1 / 7 (14.29%)
    1 / 18 (5.56%)
    3 / 24 (12.50%)
    1 / 19 (5.26%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    5 / 117 (4.27%)
    10 / 193 (5.18%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    1
    0
    0
    1
    1
    2
    1
    1
    1
    3
    1
    1
    0
    2
    2
    0
    1
    0
    0
    0
    7
    12
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    8 / 31 (25.81%)
    2 / 15 (13.33%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    11 / 117 (9.40%)
    11 / 193 (5.70%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    13
    2
    1
    0
    0
    0
    0
    0
    0
    16
    16
    Hyperglycaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    1 / 10 (10.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    8 / 31 (25.81%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    1 / 1 (100.00%)
    0 / 2 (0.00%)
    8 / 117 (6.84%)
    9 / 193 (4.66%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    4
    4
    0
    1
    0
    0
    12
    0
    0
    0
    1
    0
    0
    3
    0
    12
    16
    Hyperkalaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    5 / 31 (16.13%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    5 / 117 (4.27%)
    7 / 193 (3.63%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    5
    0
    0
    0
    1
    0
    0
    0
    0
    5
    7
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    3 / 31 (9.68%)
    1 / 15 (6.67%)
    1 / 15 (6.67%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    5 / 117 (4.27%)
    5 / 193 (2.59%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    5
    2
    1
    0
    0
    0
    0
    0
    0
    8
    8
    Hyperuricaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 52 (0.00%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    7 / 31 (22.58%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    8 / 117 (6.84%)
    8 / 193 (4.15%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    10
    2
    0
    0
    0
    0
    0
    0
    0
    12
    12
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    1 / 7 (14.29%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    4 / 52 (7.69%)
    2 / 10 (20.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    6 / 31 (19.35%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    1 / 3 (33.33%)
    2 / 14 (14.29%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    12 / 117 (10.26%)
    16 / 193 (8.29%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    1
    1
    0
    0
    5
    3
    0
    0
    0
    1
    7
    3
    0
    1
    0
    1
    2
    0
    0
    15
    20
    Hypocalcaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 11 (9.09%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    3 / 117 (2.56%)
    5 / 193 (2.59%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    1
    0
    1
    0
    0
    2
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    3
    5
    Hypokalaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    1 / 59 (1.69%)
    1 / 7 (14.29%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    1 / 15 (6.67%)
    2 / 15 (13.33%)
    0 / 18 (0.00%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    4 / 117 (3.42%)
    5 / 193 (2.59%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    2
    3
    0
    0
    0
    0
    0
    0
    6
    7
    Hypomagnesaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    2 / 11 (18.18%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    1 / 7 (14.29%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    6 / 52 (11.54%)
    2 / 10 (20.00%)
    0 / 7 (0.00%)
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 19 (5.26%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    2 / 15 (13.33%)
    1 / 18 (5.56%)
    1 / 19 (5.26%)
    0 / 3 (0.00%)
    1 / 14 (7.14%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    6 / 117 (5.13%)
    12 / 193 (6.22%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    1
    1
    1
    1
    0
    0
    6
    2
    0
    0
    0
    1
    1
    0
    2
    1
    1
    0
    1
    0
    0
    6
    12
    Hyponatraemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    1 / 59 (1.69%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 8 (12.50%)
    0 / 9 (0.00%)
    2 / 52 (3.85%)
    0 / 10 (0.00%)
    1 / 7 (14.29%)
    1 / 18 (5.56%)
    2 / 24 (8.33%)
    4 / 19 (21.05%)
    6 / 31 (19.35%)
    1 / 15 (6.67%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    12 / 117 (10.26%)
    16 / 193 (8.29%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    1
    1
    0
    0
    1
    0
    2
    0
    1
    1
    2
    4
    6
    1
    0
    1
    0
    0
    0
    0
    0
    12
    16
    Hypophosphataemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 12 (8.33%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
    2 / 59 (3.39%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 8 (0.00%)
    2 / 9 (22.22%)
    2 / 52 (3.85%)
    2 / 10 (20.00%)
    1 / 7 (14.29%)
    1 / 18 (5.56%)
    3 / 24 (12.50%)
    2 / 19 (10.53%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    1 / 15 (6.67%)
    2 / 18 (11.11%)
    3 / 19 (15.79%)
    1 / 3 (33.33%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    7 / 117 (5.98%)
    12 / 193 (6.22%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    2
    0
    1
    0
    2
    2
    2
    1
    1
    3
    2
    1
    0
    1
    2
    4
    2
    0
    0
    0
    8
    13
    Iron deficiency
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
    0 / 59 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    1 / 52 (1.92%)
    0 / 10 (0.00%)
    0 / 7 (0.00%)
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 19 (0.00%)
    1 / 31 (3.23%)
    0 / 15 (0.00%)
    0 / 15 (0.00%)
    1 / 18 (5.56%)
    0 / 19 (0.00%)
    0 / 3 (0.00%)
    0 / 14 (0.00%)
    0 / 1 (0.00%)
    0 / 2 (0.00%)
    2 / 117 (1.71%)
    3 / 193 (1.55%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    2
    3

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Apr 2016
    1) Added rationale for sentinel subject approach 2) Added additional rationales for 6 weeks DLT in dose escalation, and for initiation of PD substudy 3) Revised treatment arms and sample sizes for PD substudy 4) Revised vital sign measurements during infusions 5) Procedure clarifications and typographic changes
    31 May 2016
    1) Revised Target Population in Inclusion Criteria in Section 3.3.1 2) Revised Dose-limiting Toxicities in Section 4.5.1
    06 Jun 2016
    1) Clarified rationales for 2 week lead-in and for dose selection in Sections 1.1.3 and 1.1.5.1, respectively 2) Added a 9 day waiting period for doses over 400 mg, and revised waiting periods for each dose level Sections 1.1.7 and 3.1.1, respectively 3) Clarified definition of treatment arm and number of arms in Part 1B inSections 3.1.2 and 8.3.1 4) Clarified requirement for dose delay in Part 1A in Section 4.5.4 5) Added language to allow for collection and central review of imaging assessments in Section 5.4 6) Editorial changes throughout the protocol
    26 Oct 2016
    1) Included updates made in nivolumab IBv15 in Sections 1.4.4, 3.3.1, and Appendix 1, respectively 2) Added text describing vascular effects in mouse models in literature, and added dose delay in Section 1.5 3) Prohibited use of dipyridamole 2 weeks prior to the first dose and during treatment in Section 3.4.1 4) Removed windows for dosing visits and further clarified minimum treatment interval between 2 doses in Sections 5.1 and 4.5, respectively 5) Revised and clarified requirements for minimum dosing interval, dose delay due to toxicity, medical events or non-medical events, hepatic nonhematologic DLT, and removed tumor assessment procedure when study drugs are permanently discontinued in Section 4.5 6) In Section 5.1, revised Vital Signs requirements during initial treatment and re-treatment in Parts 1B and 2, removed pregnancy test on Days 8 and 22 during retreatment in Q1W, and added windows for tumor assessment during follow-ups 7) Clarified DILI criteria for subjects with abnormal ALT or AST at baseline in Section 6.6 8) Added 1 new reference in Section 12 9) Editorial changes throughout the protocol
    16 Mar 2017
    Incorporates Administrative Letters 01 and 02, and Amendments 01, 02, 03, 05 and 07
    16 Mar 2017
    1) Included additional exclusion criteria for cardiovascular and cerebrovascular disease in Section 3.1.2 2) Added a new Section 3.4.4 to ensure appropriate assessment and management of cardiovascular risk factors 3) Updated dose delay criteria for subjects with any investigation or symptoms suggestive of possible thrombotic or ischemic events during treatment in Section 4.5.4.1 4) Updated guidelines to permanently discontinue BMS-986179 in subjects with any myocardial infarction or thrombotic/ischemic cerebrovascular event during treatment in Section 4.5.6
    20 Oct 2017
    1) Changed the tumor types in Part 2, Cohort Expansion to add nonsmall cell lung cancer (NSCLC), renal cell cancer (RCC), castrateresistant prostate carcinoma, squamous cell carcinoma of the head and neck, and melanoma, and to delete ovarian cancer, colorectal cancer, and gastric cancer 2) Allowed for monotherapy in Part 2 with BMS-986179 in NSCLC and RCC, with the option for subjects to receive combination therapy with BMS-986179 and nivolumab at disease progression 3) Changed the treatment duration to 2 years, changed follow-up to 3 years after initial dose, and added a Q4W regimen for combination therapy with BMS-986179 and nivolumab 4) Added plasma sample collection for ctDNA extraction for assessment of tumor mutational burden in Section 5.7.1.6 5) Added laboratory parameters HbA1c, cardiovascular lipid profile, and PSA to list of assessments in Section 5.3.2 6) Added clinical observations and supporting data throughout Section 1.1 7) Added a replacement criterion to allow subjects without both pre- and on-treatment tumor biopsies, or whose biopsies are uninformative, to be replaced 8) Increased the number of pre-treatment core biopsy specimens from 2 to either 4 (for NSCLC, melanoma, and SCCHN) or 3 (for all other tumor types) 9) Changed the name of the Study Director/Medical Monitor 10) Editorial changes throughout the protocol
    28 Feb 2018
    1) Subcutaneous dosing objective has been added to Part 1B of this study to assess a potentially important alternative approach to dosing. 2) Added background for rHuPH20, which enables SC administration of BMS-986179. 3) Sections added or modified based on addition of objective to assess tumors using iRECIST criteria by BICR. 4) New PK tables were added to support assessment for PK in subjects receiving subcutaneous dose.
    30 Nov 2018
    1) Selection strategy has been modified based on new data on adenosineaxis that is more specific to the pathway being targeted by BMS-986179. 2) Data from completed toxicokinetics study has been added to provide additional safety information. 3) Part 2 expansion cohorts in the tumor-specific indications with high unmet medical need are open. Cardiovascular disease is prevalent in these indications. 4) Cardiovascular exclusion criteria has been modified. Under this modification, some asymptomatic patients with history of cardiovascular disease may be permitted to enroll after mandatory evaluation by specialist that includes functional ischemic test.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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